CardioDex says that initial use of its femoral access site closure device has demonstrated safety and ease of use in a wide range of patients, including those with challenging anatomy.
The data comes from commercial use of the device on 41 patients at St Marien Hospital in Siegen, Germany, which showed 100 per cent success rate and no complications. The CardioDex thermal femoral artery closure device was used in 25 diagnostic cases and 16 interventional cases. The completion rate was obtained for normal or diseased femoral vessels with calcified plaque. According to Dr Shimon Eckhouse, Chairman and founder of CardioDex, the results support the data observed in the company's first single-centre trial and "opens the door" to improvements in femoral arterial access and closure.
The mechanism of action of the CardioDex device is based on controlled thermal closure of the arterial puncture site. The device consists of a temporary Nitinol anchor which is delivered via an existing introducer sheath and used to locate the puncture site. The fully controlled heating step is made possible by an integrated battery power unit and a heating system that is inserted over the Nitinol anchor wire on the site of the arteriotomy. Local short heating pulses provide sufficient haemostasis through the cross linking of collagen, leaving no residual material at the puncture site.
According to CardioDex, the market for percutaneous femoral access and vascular closure devices has grown significantly since they were first launched in the early 1990. While some of the newer closure devices can be used in what was considered to be patients at high risk such as those with peripheral arterial disease (PAD) and smaller calibre arteries, the CardioDex device can be used in all types of patients and situations, including bifurcations, PAD, SFA (superficial femoral arterial) punctures as well as in very thin or obese patients.